格隆汇9月29日丨恒瑞医药(01276.HK)发布公告，2025年9月29日耗资人民币7370.23万元回购108万股A 股，回购价格每股67.8-69.33元。 ...

Core Insights - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of four injectable drugs, including SHR-7787, SHR-4849, Bevacizumab, and Adebali monoclonal antibody [1][2] Group 1: Drug Approvals - The company’s subsidiaries have been granted clinical trial approval for SHR-7787, a first-class therapeutic biological product that activates T cells to target and kill tumor cells, with no similar drugs currently approved in China [1] - SHR-4849 is an antibody-drug conjugate targeting DLL3, designed to specifically bind to DLL3 antigens on tumor cells, leading to the release of cytotoxic agents to kill cancer cells, aimed at treating advanced malignant solid tumors [1] Group 2: Existing Products - Bevacizumab, a humanized anti-VEGF monoclonal antibody, was co-developed by Genentech and is currently marketed globally, including in China [2] - Adebali monoclonal antibody is a humanized anti-PD-L1 monoclonal antibody developed by the company, which aims to block the PD-1/PD-L1 pathway to reactivate the immune system against tumors [2]

Core Insights - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of four injectable drugs, including SHR-7787, SHR-4849, Bevacizumab, and Adebali monoclonal antibody [1][2] Group 1: Drug Approvals - The company’s subsidiaries have been granted clinical trial approval for SHR-7787, a first-class therapeutic biological product that activates T cells to target and kill tumor cells, with no similar drugs currently approved in China [1] - SHR-4849 is an antibody-drug conjugate targeting DLL3, designed to specifically bind to DLL3 antigens on tumor cells, leading to the release of cytotoxic agents to kill cancer cells, aimed at treating advanced malignant solid tumors [1] Group 2: Existing Products - Bevacizumab, a humanized anti-VEGF monoclonal antibody, was co-developed by Genentech and Roche, approved in the US in 2004, and is currently marketed in China and globally [2] - Adebali monoclonal antibody is a humanized anti-PD-L1 monoclonal antibody developed by the company, which blocks the PD-1/PD-L1 pathway to reactivate the immune system's anti-tumor activity [2]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-155 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司苏州盛迪亚 生物医药有限公司、上海恒瑞医药有限公司、上海盛迪医药有限公司收到国家药 品监督管理局（以下简称"国家药监局"）核准签发关于 SHR-7787 注射液、 SHR-4849 注射液、贝伐珠单抗注射液、阿得贝利单抗注射液的《药物临床试验 批准通知书》，将于近期开展临床试验。现将相关情况公告如下： 二、药品的其他情况 SHR-7787 注射液为 1 类治疗用生物制品，通过诱导激活 T 细胞，使其发挥 靶向杀伤肿瘤细胞的作用。目前国内尚无同类药物获批上市。截至目前，SHR-7787 注射液相关项目累计研发投入约为 4,893 万元。 药品名称 SHR-7787 注射液 SHR-4849 注射液 贝伐珠单抗 注射液 阿得贝利单抗 注射液 剂型 注射剂 申请事项 临床试验 受理号 CXSL ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-154 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 受 理 号：CXHL2500661、CXHL2500662、CXHL2500663、CXHL2500664 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 7 月 8 日受理的 HRS-2129 片符合药品注册的有关要求，同意开展成人糖尿病 性周围神经病理性疼痛、成人骨关节炎疼痛适应症的临床试验。 二、药物的其他情况 HRS-2129 片拟用于治疗急慢性疼痛。经查询，目前国内尚无同靶点药物获 批上市。截至目前，HRS-2129 片相关项目累计研发投入约为 11,240 万元。 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司山东盛迪医 药有限公司、上海恒瑞医药有限公司收到国家药品监督管理局（以下简称"国家 药监局"）核准签发关于 HRS-2129 片的《药物临床试验批准通知书》，将于近 期开展临床试验。现将 ...

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of HRS-2129 tablets, aimed at treating acute and chronic pain, with no similar drugs currently approved in the domestic market [1] Group 1: Company Developments - The company's subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., and Shanghai Heng Rui Medicine Co., Ltd. have been authorized to conduct clinical trials for HRS-2129 tablets [1] - The total research and development investment for the HRS-2129 project has reached approximately 11.24 million yuan [1] Group 2: Market Context - There are currently no approved drugs targeting the same mechanism as HRS-2129 in the domestic market, indicating a potential competitive advantage for the company [1]

智通财经APP讯，恒瑞医药(600276.SH)发布公告，近日，公司子公司山东盛迪医药有限公司、上海恒 瑞医药有限公司收到国家药品监督管理局(简称"国家药监局")核准签发关于HRS-2129片的《药物临床试 验批准通知书》，将于近期开展临床试验。 HRS-2129片拟用于治疗急慢性疼痛。经查询，目前国内尚无同靶点药物获批上市。截至目前，HRS- 2129片相关项目累计研发投入约为11,240万元。 ...

格隆汇9月29日丨恒瑞医药(600276.SH)公布，公司子公司山东盛迪医药有限公司、上海恒瑞医药有限公 司收到国家药品监督管理局核准签发关于HRS-2129片的《药物临床试验批准通知书》，将于近期开展 临床试验。HRS-2129片拟用于治疗急慢性疼痛。 ...

Core Viewpoint - Heng Rui Medicine (600276) announced the approval of clinical trial notifications for multiple drug candidates by the National Medical Products Administration, indicating a significant step forward in its research and development pipeline [1] Group 1: Clinical Trial Approvals - Subsidiaries Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Heng Rui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd. received approval for clinical trials of SHR-7787 injection, SHR-4849 injection, Bevacizumab injection, and Adebali monoclonal antibody injection [1] - Subsidiaries Shandong Shengdi Medicine Co., Ltd. and Shanghai Heng Rui Medicine Co., Ltd. also received approval for clinical trials of HRS-2129 tablets [1]

每经AI快讯，9月29日，恒瑞医药（600276）(600276.SH)公告称，公司子公司山东盛迪医药有限公司、 上海恒瑞医药有限公司收到国家药监局核准签发关于HRS-2129片的《药物临床试验批准通知书》，同 意开展成人糖尿病性周围神经病理性疼痛、成人骨关节炎疼痛适应症的临床试验。HRS-2129片拟用于 治疗急慢性疼痛，目前国内尚无同靶点药物获批上市。截至目前，该项目累计研发投入约为1.12亿元。 根据相关法律法规要求，药物在获得药物临床试验批准通知书后，尚需开展临床试验并经国家药监局审 评、审批通过后方可生产上市。 ...